Novavax, Inc. (Nasdaq:NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. NanoFlu, its quadrivalent influenza nanoparticle vaccine, is currently in a pivotal Phase 3 clinical trial to address key factors that can lead to the poor effectiveness of currently approved flu vaccines. ResVax, its RSV vaccine for infants via maternal immunization, is the only vaccine to demonstrate efficacy in a Phase 3 clinical trial. Novavax recently initiated development of a vaccine program against COVID-19. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.
We are currently preparing for process validation and licensure of a late phase seasonal influenza vaccine and beginning phase I clinical work for a vaccine against the SARS-nCoV-2 novel Coronavirus. To assist with these programs we are seeking a CMC Project Manager who is responsible for drug substance CMC-related activities across the Novavax product portfolio, including development, tech transfer, manufacturing, and supply of clinical drug substance (DS). The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.
Responsibilities include, but are not limited to:
Overall responsibility for all downstream drug substance activities from preclinical development through commercial supply
Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of DS in support of ongoing clinical programs
Delivery of robust, scalable and cost-effective manufacturing processes that meet or exceed the target clinical profile
In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CDMOs are using systems and processes in compliance with all relevant regulatory standards
Oversee execution of the validation of downstream DS processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
Assisting with the writing and reviewing documents for INDs / regulatory section submissions
Prepare, review, or edit cGMP batch records, CMC regulatory, and Quality documents
Provide input on process development strategies, overseeing CDMO development through clinical and pre-commercial stages
Provide technical/team support and leadership for technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. media, buffers and cleaning solutions
Collaboration with other CMC team members to build and execute the CMC development plan
MS or BS in science or engineering, plus at least 4 years of experience in pharmaceutical CMC
Proven experience in collaborating in matrix teams in a technical environment
Strong program management and project management skills and adept at working collaboratively with cross functional teams
Strong interpersonal and communication skills
Experience in oversight of CDMOs for process development, characterization, technology transfer, and release
Knowledge of CMC development from pre-clinical through clinical to commercialization
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.
Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Equal Opportunity Employer/Veterans/Disabled
Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.